BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SURGICAL CHISEL

    K Number: K760959 · Decision Nov 15, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    14

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    Basic Information

    Device Name
    SURGICAL CHISEL
    K Number
    K760959
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    American Safety Equipment Corp.
    Date Received
    November 1, 1976
    Decision Date
    November 15, 1976
    Product Code
    EMM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EMM Chisel, Osteotome, Surgical

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